Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bluewind Medical , Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253651 | Revi System | Bluewind Medical , Ltd. | 2026-07-28 | 250 | 0 |
| K252391 | Revi System | Bluewind Medical , Ltd. | 2025-12-12 | 134 | 0 |
| K240037 | Revi™ System | Bluewind Medical , Ltd. | 2024-05-02 | 118 | 0 |
| DEN220073 | Revi System | Bluewind Medical , Ltd. | 2023-08-16 | 315 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda